COLD CD ASP MODULE, ITE— 510(k) K933041

Substantially Equivalent

Electone, Inc.

FDA 510(k) clearance K933041 for COLD CD ASP MODULE, ITE, Substantially Equivalent on 1993-08-02. Applicant: Electone, Inc..

Clearance details

Applicant: Electone, Inc.
Product code: Code LRS
Advisory panel: General Hospital
Date received: 1993-04-28
Decision date: 1993-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longwood, FL, US

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Adverse events under product code LRS

product code LRS

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.